Mazor X Stealth Versus O-arm Navigation for Pedicle Screw Insertion (RGNV)

P. D. Dr. med. Duccio BOSCHERINI

Status: Unknown

Conditions: Disorder of Spine

Treatments: Device: Guidance for pedicle screw insertion (Mazor Stealth); Device: Guidance for pedicle screw insertion (O-arm Navigation)

Study type: Interventional

Funder types: Other

Identifiers

NCT04353895

2020-00305

Details and patient eligibility

About

The investigators would like to investigate the fluoro-registered Mazor X Stealth in terms of pedicle screw accuracy and radiation exposure in comparison with the O-arm and navigation as the institutional gold standard.

Full description

Pedicle screw insertion for spinal fusion is a surgical procedure regularly performed around the world. Surgeons use free-hand, navigation or robotic techniques. The navigation began in 1995 in spine surgery. Surgical navigation systems provide pedicle screw insertion by projecting screw trajectories on a three-dimensional (3D) image acquisition, preoperatively or during the surgical procedure. Laine et al reported better accuracy and safety in pedicle screw insertion using the navigation system. Other authors reported less irradiation with the use of computer-assisted navigation. Robotic guidance was introduced in 2006 and assists the surgeon through a mechanical guidance according to a planning of screw trajectories on 3D imaging. This technique allows stable guidance for pedicle drilling and screw insertion, leading to greater screw positioning in lumbar fusion.

Medtronic (Medtronic, Minneapolis, MN, USA) introduced the Mazor X Stealth in Europa in 2019, including the Mazor robotic device with the navigation technology within the same system. The hypothesis would be a combination of the stability of the robot during screw insertion and the accuracy of the navigation with cumulative benefit from the two techniques.

The goal of this study is to compare radiological and clinical results of the use of the new Mazor Stealth with the surgical O-arm navigation during pedicle screw insertion for posterior lumbar fusion.

Enrollment: 36 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult patients
• who require pedicle screw insertion for vertebral posterior stabilization

Exclusion criteria

• children
• participants incapable of judgment
• participants under tutelage
• vertebral fusion indication without pedicle screw implantation
• refusal to participate
• data missing for radiation exposure calculation
• unstable vertebral fracture requiring urgent fixation
• pregnancy
• refusal to participate

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Robotic group (RG)

Experimental group

Description:

Patients in the RG group will be operated using the assistance of the Mazor X Stealth robot

Treatment:

Device: Guidance for pedicle screw insertion (Mazor Stealth)

O-arm navigation group (NV)

Active Comparator group

Description:

Patients in the NV group will be operated using the guidance of the Stealth navigation

Treatment:

Device: Guidance for pedicle screw insertion (O-arm Navigation)